NCT07276360 Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 278 participants in total. It began in 2026-03-11 with a primary completion date of 2028-01-02.

Brief Summary

This phase II trial compares the effect of hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) when given in combination with cisplatin and brachytherapy in patients with stage IB3, II, or III cervical cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT shortens treatment duration and may reduce costs and may improve the completion rates. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HFRT may be safe, tolerable, and/or as effective as CFRT when given in combination with cisplatin and brachytherapy in treating patients with stage IB3, II or III cervical cancer.

Eligibility Criteria

Inclusion Criteria: * Females aged 18 years or older * Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment * Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC * Able to provide written informed consent in English, Luganda, Runyankole, or Lango * Willing to attend post-treatment follow-up for up to 12 months * Fit for concurrent chemotherapy with cisplatin * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 * Absolute neutrophil count ≥ 1,500 cells/mm\^3 (1.5 x 10\^9/L) * Platelets ≥ 100,000 cells/mm\^3 (100 x 10\^9/L) * Hemoglobin ≥ 9.0 g/dL * Leukocyte count ≥ 4,000 cells/mm\^3 (4.0 x 10\^9/L) * Creatinine clearance \> 60 mL/mins, calculated using the Cockcroft-gault equation for women * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the upper limit of normal (ULN) * Total bilirubin \< 2 x ULN unless attributed to the use of antiretroviral therapy (ART) * HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment Exclusion Criteria: * Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention * Clinical and/or radiological evidence of distant metastases * Prior pelvic or abdominal radiotherapy * Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment * History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment * Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated * Concurrent untreated invasive malignancy * Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements * Uncontrolled HIV infection, especially HIV viral load \> 2,000 copies/mL * Participants with CD4 counts \< 200 cells/mm\^3

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